Oral Lichen Planus
Conditions
Keywords
Antioxidant, Lycopene, Prednisolone
Brief summary
Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for the treatment of oral lichen planus. Half of participants (total number of participants was twenty eight) were received lycopene and the other half were received prednisolone.
Detailed description
Prednisolone and lycopene were produced remission of lesions in oral lichen planus patients, but they do so by different mechanisms. The main cause of oral lichen planus is still unknown. Some authors advocate the disease appears to be a result of T-cell-mediated autoimmune responses in oral epithelial tissues. But, recent study suggests that increased reactive oxygen species (ROS) and lipid peroxidation together with an imbalance in the antioxidant defense system may play a part in the generation of disease. Lycopene exerts its antioxidant activity by physical and chemical quenching of free radicals and decreases free radicals-initiated oxidative reactions, particularly lipid peroxidation and DNA oxidative damage, thereby preventing tissue damage. Prednisone have both anti-inflammatory and immunosuppressant effects.It suppresses the inflammatory response by limiting the recruitment of inflammatory cells and inhibiting synthesis of pro-inflammatory products such as prostaglandins (PGs), leukotrienes (LTs) and platelet activating factors (PAF) by indirectly inhibiting phospholipase A2 and negative regulating cyclooxygenase (COX-2).
Interventions
DRUGlycopene
Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
DRUGPrednisolone
Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
Sponsors
B.P. Koirala Institute of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject had symptomatic i.e. burning sensation and/or pain secondary to oral lichen planus. * Subject had clinically & histo-pathologically diagnosed as oral lichen planus. * Subject had not on any treatment for the same or treatment likely to modify their oral lichen planus (e.g. systemic steroids, antifungals, immunosuppressant's, anti-oxidant).
Exclusion criteria
* Suffering from any systemic disease/s such as diabetes, hypertension, cardiovascular, respiratory system disease, renal dysfunction, liver disorders, malignancy, active peptic ulcer diseases, acute gastrointestinal diseases, anemia and glaucoma, etc. * Suffering from serious or recurrent infection, immunodeficiency or HIV. * Pregnant or breast feeding (including women who wish to be pregnant during the study period). * Any other mucosal diseases or any other skin diseases which might be associated with oral lesions. * On any drug therapy which might be causes lichen planus like lesions. * Known allergy or contraindication to study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score | 8 weeks minus baseline | Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion \<1 cm2; score 2: lesion 1-3 cm2; score 3= lesion \>3 cm2. Ulceration: score 0= no lesion; score 1= lesion \<1 cm2; score 2= lesion 1-3 cm2; score 3= lesion \>3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 & 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome & zero value represent no lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burning Sensation or Pain by Using NRS (Numerical Rating Scale) | 8 weeks minus baseline | Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score. |
Participant flow
Recruitment details
Only symptomatic oral lichen planus patients, who were fulfill inclusion and exclusion criteria, were selected and recruited from the outpatient department of Oral Medicine and Radiology, College of dental surgery, BPKIHS on the basis of randomization list. The first patients was recruited on 21/02/2013 and the last patients was on 28/01/2014.
Pre-assignment details
Before enrollment, full explanation about the study was given and written informed consent was taken. A detailed clinical history, clinical examination,baseline investigations and punch biopsy were taken. Patient was on treatment with medication for the same lesions asked to stop the treatment and a washout period of 3 weeks was given.
Participants by arm
| Arm | Count |
|---|---|
| Lycopene Group Lycopene- 4 mg capsule by mouth single dose per day for 2 months | 13 |
| Prednisolone Group Prednisolone- 40 mg capsule by mouth single dose per day for 2 months | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Lycopene Group | Prednisolone Group | Total |
|---|---|---|---|
| Age, Continuous | 41.69 years STANDARD_DEVIATION 13.97 | 48.07 years STANDARD_DEVIATION 12.27 | 45.11 years STANDARD_DEVIATION 13.24 |
| Baseline NRS (numerical rating scale) burning sensation score | 3.69 Scores on a scale STANDARD_DEVIATION 1.75 | 3.60 Scores on a scale STANDARD_DEVIATION 2.03 | 3.64 Scores on a scale STANDARD_DEVIATION 1.87 |
| Piboonniyom REU (Reticular, Erythematous and Ulceration) severity score | 8.23 Scores on a scale STANDARD_DEVIATION 5.85 | 8.34 Scores on a scale STANDARD_DEVIATION 7.83 | 8.28 Scores on a scale STANDARD_DEVIATION 6.86 |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 13 | 15 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
Primary
Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion \<1 cm2; score 2: lesion 1-3 cm2; score 3= lesion \>3 cm2. Ulceration: score 0= no lesion; score 1= lesion \<1 cm2; score 2= lesion 1-3 cm2; score 3= lesion \>3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 & 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome & zero value represent no lesion.
Time frame: 8 weeks minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lycopene Group | Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score | 2.15 Scores on a scale | Standard Deviation 1.68 |
| Prednisolone Group | Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score | 0.73 Scores on a scale | Standard Deviation 1.58 |
p-value: 0.004Mann Whitney test
Secondary
Burning Sensation or Pain by Using NRS (Numerical Rating Scale)
Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score.
Time frame: 8 weeks minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lycopene Group | Burning Sensation or Pain by Using NRS (Numerical Rating Scale) | 0.23 Scores on a scale | Standard Deviation 0.44 |
| Prednisolone Group | Burning Sensation or Pain by Using NRS (Numerical Rating Scale) | 0.07 Scores on a scale | Standard Deviation 0.26 |
p-value: 0.224Mann Whitney test